Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial

Completed

Phase 1/2 Results

Trial Description

The purpose of this study is determine the effects of using of a combination of two drugs--integrilin (eptifibatide) and activase (recombinant tissue plasminogen activator, rt-PA, or recombinant t-PA)--to dissolve blood clots in patients who have a stroke.

Detailed Description

The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) trial is part of the Specialized Program on Translational Research in Acute Stroke (SPOTRIAS). The overall goals of SPOTRIAS are to enhance delivery of acute stroke patient care and train acute stroke translational researchers.
Stroke most often occurs when blood flow to the brain stops because it is blocked by a blood clot. When a blood clot blocks the blood supply to the brain, parts of the brain may not get enough blood and oxygen to survive. As a result, permanent brain damage can occur, which can affect a person's ability to walk, talk, and function independently. In order to reduce the risk of permanent damage, it is important to restore blood flow to the brain as quickly as possible.
The CLEAR Stroke study will enroll 100 participants with acute stroke due to a blood clot. The purpose of this multi-center, randomized, double-blind study is to determine the effects of using a combination of two drugs, integrilin (or eptifibatide) and activase (or recombinant tissue plasminogen activator, rt-PA, recombinant t-PA), to dissolve blood clots. More specifically, the CLEAR study is being done to determine if a lower dose of activase, given in combination with a second drug, integrilin, is a safe treatment for acute stroke.
Activase, used alone, is already approved by the Food and Drug Administration (FDA) as treatment for patients with a stroke caused by blockage of an artery in the brain and when given within 3 hours of the onset of stroke symptoms. Integrilin is also already FDA-approved as a treatment for blood clots causing heart attack. The investigational aspect of this study is the use of integrilin for a stroke victim in combination with activase.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Double-Blind
  • Purpose: Treatment

Patient Involvement

Patients will be randomized into two tiers: one in which 30 patients will receive combined study drug (75 ug/kg bolus, 2 hour infusion of 0.75 ug/kg eptifibatide, 0.3 mg/kg rt-PA) and 10 controls will receive standard r-tPA (0.9 mg/kg), and one in which 35 patients will receive combined study drug (75 ug/kg bolus, 2 hour infusion of eptifibatide, 0.45 mg/kg rt-PA) and 15 will receive standard r-tPA. No participant will receive more than the calculated dose for a 100kg patient. Within all of these tiers, there will be 2 patients treated in =< 2 hours for every 5 patients treated in 2-3 hours. All patients will be co-enrolled in complementary proteomic and genomic projects.

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence of symptomatic intracerebral hemorrhage within 36 hours of treatment.
Secondary The incidence of early neurological improvement, as measured by the NIHSSS &lt;/= 2 at 24 hours from symptom onset.
Primary The primary safety endpoint in this safety study will be the incidence of symptomatic intracranial hemorrhage . within 36 hours Yes
Primary The primary measure of early beneficial drug activity will be the incidence of early neurological improvement, as measured by the NIHSSS </= 2 at 24 hours from symptom onset Yes

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